Operation Management Configuring Manufacturing Operation Management Applications
Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.
By Gloria Gadea-Lopez, PhD
Fill/Finish Single-Use Technology for Syringe Filling
A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.
By Andrea Detroy, Christian Matz , Mark Leykin, Ernest Jenness, Ross W. Acucena